Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01379365 | Cryo-Touch III Refinement Study Investigational Plan | PHASE2 | COMPLETED | 88 | — | — | Jun 1, 2011 | Dec 1, 2014 | Mar 24, 2015 | 1 | United States |
* Effectiveness endpoint: Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale. * Safety endpoint: Incidence of device-related serious adverse events (DSAE).
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cryo-Touch III | DEVICE | Percutaneous treatment with the device |
Inclusion Criteria: * Age 30-70 years * Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 2 in animation on the 5-point Wrinkle Scale (5WS)\* * Subject has signed institutional review board (IRB)-approved informed consent form Exclusion Criteria: * Subject takes a...